Vaccinating children against COVID-19 is critical to ending this pandemic, and you can help. UNC’s trial site will begin enrolling children 12-17 years of age on May 6.
Novavax is conducting a clinical trial of their COVID-19 vaccine for adolescents, 12-17 years of age. This is an expansion of its current clinical trial for adults underway in the U.S., for which UNC is a trial site. This same vaccine has already been shown to be effective and safe for adults in trials conducted in the United Kingdom (Phase 3) and South Africa (Phase 2b).
The Novavax vaccine is a protein-based vaccine, using a DNA replica of the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The vaccine contains an adjuvant molecule to further enhance the immune response.
The Novavax vaccine trial for adolescents is a placebo-controlled trial in which 2 of 3 participants will receive the vaccine and 1 in 3 participants will receive placebo. Around 6 months into the study, possibly sooner, those initially receiving placebo would receive the vaccine, guaranteeing all participants will be vaccinated.
Currently the only vaccine that has emergency use authorization (EUA) approval for adolescents 16 years of age and older is Pfizer, and they recently submitted an EUA application for adolescents aged 12-15. Health providers anticipate approval, possibly bringing the vaccine to the public as soon as the end of May 2021. Moderna is also currently conducting clinical trials with adolescents; an EUA application is anticipated in the coming months.
COVID-19 vaccines are being developed using a variety of technologies. The Moderna and Pfizer mRNA vaccines have been shown to be effective and safe but require sub-zero temperatures to remain stable before injection, which significantly limits the speed and geographic scope of current vaccine distribution. The Novavax vaccine requires only refrigeration to remain stable.
No one is fully protected against COVID-19 until many more individuals are vaccinated, worldwide. There are millions of adolescents around the world living in resource-limited countries which lag far behind the U.S. and wealthier countries in vaccine roll out.
“We need a variety of vaccines available since different vaccines may show significant differences in efficacy and longevity of protection. The only way that we learn this critical information is to continue our research,” said Cindy Gay, MD, principal investigator of UNC’s Novavax clinical trial site, associate professor in the Division of Infectious Diseases at the UNC School of Medicine, and member of the UNC Institute for Global Health and Infectious Diseases.
Participation in this trial would not only help make another vaccine available to adolescents in the U.S., but would also accelerate access to a vaccine for millions of adolescents across the globe. Please consider participating and helping to end this pandemic worldwide.
To see if you are eligible to participate in UNC’s Novavax vaccine clinical trial call 800-804-9140 or email Novavax_Study@unc.edu. You can also go through the COVID-19 Prevention Network (COVPN) Volunteer Screening Registry. To learn more about all COVID-19-related clinical trials at UNC, visit the UNC COVID-19 Clinical Research website.